Why There's (Still) No Viagra for Women

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The first "female Viagra" drug touted as boosting women's sexual
desire could be approved today, assuming the Food and Drug
Administration decides it's safe and effective.

But the odds don't look good, as the FDA has already rejected the
drug, called flibanserin, twice.

Although some organizations say that sexism is playing a role in
the drug's lack of approval, experts say safety is the main
criterion underlying the agency's rejections so far.

And even if flibanserin does get approved, it's unlikely to work
the same magic on a couple's sex life as Viagra,
said two experts, Dr. Mary Jane Minkin, a clinical professor of
obstetrics and gynecology at Yale University School of Medicine
in New Haven, Connecticut, and Dr. Elizabeth Kavaler, a urologist
at Lenox Hill Hospital in New York City.

That's because flibanserin targets sexual desire, a much more
complicated issue than the mechanics of performance, both Minkin
and Kavaler said.

Several feminist organizations have pointed out that
26 drugs are now marketed for men with sexual dysfunction,
and not a single one has been approved for women. They argue that
the FDA has repeatedly rejected flibanserin's drug approval
application because of a sexist belief that women aren't supposed
to want or need sex.

But those numbers are misleading, Minkin said, because there are
only a few active ingredients in the many drugs for men. In
addition, there are several drugs now in late-stage trials that
target low sex drive in women. For instance, the drugs Lybridos
and Lybrido, made by the company Emotional Brain, combine
testosterone
with either sildenafil, the active ingredient in Viagra; or
BuSpar, an anti-anxiety drug, with the aim of treating women with
low libido.

The real issue for the FDA is not
sexism, Minkin said, but whether the drug works safely.
Sprout Pharmaceuticals, which makes flibanserin, has not yet
adequately demonstrated that the drug is both safe and effective,
she said.

"The data they brought last time did not seem appropriate to lead
to the approval of the drug," Minkin said.

Flibanserin is thought to
boost libido by altering levels of brain chemicals such as
dopamine and serotonin, which are known to play a role in
feelings of desire, motivation, appetite and satiety.

But it is far from a miracle pill. In past trials, premenopausal
women who took the drug reported, on average, gaining less than
one additional pleasurable sexual experience per month, and some
experienced side effects such as nausea, dizziness and
drowsiness, Minkin said.

The need to take the drug daily is what "raises toxicological
concerns that make it appropriate for the FDA to subject
flibanserin to elevated safety scrutiny," the letter said. In the
early trials of the drug, there were reports of substantial
side effects, and some women dropped out of the trials, according
to the letter.

Vague diagnosis

On top of that, there isn't really a clear way for doctors to
decide whether a person's level of desire is normal, or needs
fixing, Kavaler said. And without a clear measure of the drug's
effectiveness, the FDA must base its decision solely on safety,
she said.

"All you can measure is safety, and so you better have a safety
profile that's pretty much like taking a sugar pill," Kavaler
told Live Science.

It's possible that, today (June 4), Sprout Pharmaceuticals will
produce new safety and effectiveness data that could tip the FDA
in its favor, Minkin said.

Even the comparison between Viagra and flibanserin is faulty,
Minkin said.

"They're very different drugs," Minkin told Live Science.

Viagra helps men who already want to have sex actually do so, by
increasing blood flow to the penis, Minkin said. In contrast,
flibanserin targets premenopausal women who are physically able
to have pain-free and pleasurable sex but are never in
the mood, Minkin said.

Spurring any kind of desire with just a pill is tricky, Kavaler
said.

"How do you make somebody want to have sex? How do you make
someone want to go to work in the morning? I don't know how a
pill does that, because there are so many aspects to desire,"
Kavaler told Live Science.

"Why is it that divorced women who date are interested in sex, or
young women who date are interested in sex, but you can take a
35-year-old who's got two kids — why would she want to have sex?
She wants to go to sleep."

Minkin noted that drugs like flibanserin are being developed
because many women with low libidos perceive their lack of desire
as a serious problem.

What's really sexist is framing the issue of low
sexual desire as just a woman's problem, Kavaler said.

"Plenty of women complain that their husbands are totally not
interested" in sex, she said.